Pre-emption and States' Rights

As national and international marketers, pharmaceutical companies generally champion federal pre-emption of state laws to gain uniform rules governing drug promotion, research, labeling, and other activities. States have launched various efforts over the years to permit drug importing, regulate drug sales and promotion, require disclosure of certain industry activities, and establish systems for tracking drugs through the supply chain. The usual industry response is to call for national standards, as authorized by the Food, Drug and Cosmetic Act (FDCA).

These issues have moved to center stage recently as states have launched "right-to-try" laws designed to help dying or seriously ill patients gain early access to experimental therapies (see "Compassionate Use Requests Complicate Drug Development" in Pharm Exec's June 2014 issue). Although FDA routinely approves such compassionate use requests from sponsors, state officials and patient advocates believe their efforts will facilitate the process by allowing a physician to request access to drugs in early clinical trials, eliminating FDA review of these proposals. Local advocates also hope the new policies will put more pressure on biopharma companies to provide a requested treatment, although neither state nor federal agencies can require such action by a private firm.

The larger danger of the new law in Colorado and proposals in Missouri, Louisiana, and Arizona is that they may offer false hope to patients and could erode confidence in FDA's authority to set standards for clinical research and to determine which drugs are sufficiently safe and effective to come to market. Sponsors of new drug development programs generally believe that broader patient access to a promising therapy can be achieved best by completing clinical trials and gaining FDA market approval. FDA, moreover, is not pleased at the potential for state laws to challenge its authority on drug approvals and to raise the risk of patients receiving therapies that turn out to be ineffective and even harmful.